[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587462":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":38,"locations":47,"responsibleParty":65,"collaborators":12,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":12,"enrollmentInfo":78,"targetDuration":12,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":50,"whyStopped":12,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of Eastern Piedmont","OTHER",[8,13,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"A - treatment of physician choice","NO_INTERVENTION","Conventional anti-cancer treatment, according to the molecular subtype and standard of care; all patients in Arm A will also receive general recommendations on lifestyle, including weight control and physical activity as indicated by WHO and EUSOMA criteria (control arm).",null,{"label":14,"type":15,"description":16,"interventionNames":17},"B - nutritional supplementation","EXPERIMENTAL","Conventional anti-cancer treatment, according to the molecular subtype plus nutritional supplementation.\n\nPatients will be required to take on a daily basis two main long-chain polyunsaturated fatty acids omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), respectively at a dose of 700mg and 240mg, through 1 softgel twice a day. Besides, patients will be provided with a source of palmitoleic acid (hexadecenoic acid) equivalent to 1000mg of pure palmitoleic acid on a daily basis, through one daily 7 ml vial.",[18],"Dietary Supplement: omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid)",{"label":20,"type":15,"description":21,"interventionNames":22},"C - physical activity","Conventional anti-cancer treatment, according to the molecular subtype plus indication for supervised physical exercise",[18],{"label":24,"type":15,"description":25,"interventionNames":26},"D - nutritional supplementation plus physical activity","Conventional anti-cancer treatment, according to the molecular subtype plus indication for supervised exercise training plus nutritional supplementation",[18],[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":12},"DIETARY_SUPPLEMENT","omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid)","Nutritional supplements",[14,20,24],[34],{"name":35,"affiliation":36,"role":37},"Alessandra Gennari, MD","University of Piemonte Orientale","STUDY_CHAIR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":12,"email":43},"Carmen Branni, BSc","CONTACT","+3903213732292","carmen.branni@uniupo.it",{"name":45,"role":41,"phone":42,"phoneExt":12,"email":46},"Ida Taglialatela, MD","ida.taglialatela@maggioreosp.novara.it",[48],{"facility":49,"status":50,"city":51,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"AOU Maggiore della Carità","RECRUITING","Novara","28100","Italy","IT",{"type":56,"coordinates":57},"Point",[58,59],8.62118,45.44694,{"lat":59,"lon":58},[62],{"name":63,"role":41,"phone":12,"phoneExt":12,"email":64},"Alessandra Gennari","alessandra.gennari@uniupo.it",{"type":66,"investigatorFullName":63,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100587462","impact-of-targeted-nutritional-apport-and-exercise-on-the-modulation-of-metabolic-and-immune-related-gene-expression-signatures-in-early-breast-cancer-ebc-patients-candidate-to-neoadjuvant-therapy-nat-100587462",false,"NCT06928701","Impact of \"Targeted\" Nutritional Apport and Exercise on the Modulation of Metabolic and Immune-related Gene Expression Signatures in Early Breast Cancer (eBC) Patients Candidate to Neoadjuvant Therapy (NAT)","A Phase II Randomized Trial to Evaluate the Impact of \"Targeted\" Nutritional Apport and Exercise on the Modulation of Metabolic and Immune-related Gene Expression Signatures in Early Breast Cancer (eBC) Patients Candidate to Neoadjuvant Therapy (NAT)","NEOMET","Inclusion Criteria:\n\n* \\- Women (regardless of menopausal status) ≥ 18 years of age\n* Pathologic confirmation of breast cancer by tumor biopsy\n* Immunohistochemical assessment (as per local standards) of ER and PgR status, HER2 status;\n* Stage I-III breast cancer without evidence of distant metastases\n* Being candidate to standard neoadjuvant therapy\n* Having available tumor tissue from breast and\u002For lymph node at baseline\n* Ability to fill a nutritional daily diary\n* Medical clearance for non-agonistic physical activity\n* Written informed consent to study-specific procedures\n\nExclusion Criteria:\n\n* \\- locally advanced or inflammatory or stage IV BC;\n* tumor size \\\u003C 1 cm with negative nodes (pT1a, N0);\n* chronic diseases or orthopedic issues that might interfere with ability to undertake a dietary and physical activity program;\n* personal history of eating disorders.\n* women engaged in agonistic\u002Fvigorous sport activities, not able to be compliant to exercise schedules","FEMALE","18 Years",{"count":79,"type":80},160,"ESTIMATED","INTERVENTIONAL",[83],"NA","NEOMET is an exploratory randomized prospective, multicenter study whose primary aim is to explore if metabolomic signatures can be modified by a lifestyle intervention including dietary supplements and physical exercise intervention, in eBC patients candidate to NAT. Eligible patients will be randomised to one of 4 groups: A. NAT, according to molecular subtype; B. NAT plus nutritional supplementation; C. NAT plus supervised physical exercise; D. NAT plus supervised physical exercise plus nutritional supplementation. Nutritional supplementazion will consist of two main long-chain polyunsaturated fatty acids omega-3 (n-3 Lc-PUFA), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) plus a source of palmitoleic acid (hexadecenoic acid).",[86,87],"Early Breast Cancer","Neoadjuvant Treatment",[89,90,91],"treatment response","metabolomics","nutritional intervention","2025-04-07",{"date":94,"type":95},"2025-04-15","ACTUAL",{"date":97,"type":95},"2024-09-01",{"date":99,"type":80},"2026-12",{"name":5,"class":6},1]